A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01600092
First received: May 14, 2012
Last updated: April 13, 2015
Last verified: April 2015
  Purpose

A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.


Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: RotaTeq™ experimental formulation
Biological: RotaTeq™ existing formulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] [ Time Frame: 42 days after vaccination 3 (up to 185 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability [ Time Frame: Up to 7 days after any vaccination (up to 147 days) ] [ Designated as safety issue: Yes ]
    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.

  • Number of Participants With Tier-1 Adverse Events: Intussusception [ Time Frame: Up to Day 185 ] [ Designated as safety issue: Yes ]
    The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception

  • Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A [ Time Frame: 42 days after vaccination 3 (up to 185 days) ] [ Designated as safety issue: No ]
  • Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] [ Time Frame: Baseline and 42 days after vaccination 3 (up to 185 days) ] [ Designated as safety issue: No ]

Enrollment: 1020
Study Start Date: April 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RotaTeq™ Experimental Formulation
Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days)
Biological: RotaTeq™ experimental formulation
Other Name: V260
Active Comparator: RotaTeq™ Existing Formulation
Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Biological: RotaTeq™ existing formulation
Other Name: V260

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parent or legal guardian agrees to have infant participate by giving written informed consent

Exclusion Criteria:

  • History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
  • History of intussusception
  • Known or suspected impairment of immunological function, including Severe

Combined Immunodeficiency (SCID)

  • Prior administration of any rotavirus vaccine
  • Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
  • Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
  • Residing in a household with an immunocompromised person
  • Prior receipt of a blood transfusion or blood products, including immunoglobulins
  • Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
  • Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600092

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01600092     History of Changes
Other Study ID Numbers: V260-035
Study First Received: May 14, 2012
Results First Received: March 9, 2015
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastroenteritis
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 01, 2015